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[Pharmacokinetics study of amoxicillin sodium clavulanate potassium (10:1) injection in healthy volunteers].

作者信息

Miao Jia, Nan Feng, Shen Qi, Qin Yong-Ping, Wang Ying, Yu Qin, Zheng Li, Liang Mao-Zhi

机构信息

Clinical Research Unit, West China Hospital, Sichuan University, Chengdu 610041, China.

出版信息

Sichuan Da Xue Xue Bao Yi Xue Ban. 2013 Mar;44(2):246-50.

PMID:23745265
Abstract

OBJECTIVE

To study the pharmacokinetics of amoxicillin sodium clavulanate potassium (10:1) injection with different single doses intravenous infusion and one dose repeated intravenous injection in healthy volunteers for guiding the rational clinical regimen.

METHODS

Using infusion pump constantly intravenous dripping in 30 min, 4 mL blood samples were collected before and after the administration at 10 min, 20 min, 30 min, 45 min, and 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10 h. The plasma concentrations of amoxicillin and clavulanate were detected by high performance liquid chromatography- mass spectrometry/mass spectrometry method. The pharmacokinetic parameters were calculated by DAS2.0.1 software.

RESULTS

The dispositions of amoxicillin and clavulanate matched three or two compartment model with the weight coefficient 1/cc. To avoid the biases caused by compartment model fitting, the pharmacokinetic parameters were statistical moment parameters of non-compartment model. The peak concentrations, the areas under curve, the half-lifes and the clearances after single injections of 0. 55 g, 1.1 g and 2.2 g indicated that both amoxillin and clavulanate had linear dynamics characteristics. After 1.1 g single dose and multiple doses infusion, the pharmacokinetic parameters of amoxicillin and clavulanate were close respectively, and the trough concentrations before the 7th to 13th administration were lower than the detection limitation, which implied that the previous administration had cleared out before the next administration, and no accumulation happened after multiple doses.

CONCLUSIONS

The amoxicillin sodium clavulanate potassium (10:1) injection possesses the linear kinetics. The dosage regimen of 1.1 g Q8h intravenous infusion could meet the needs of clinical therapy.

摘要

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